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FACBC PET/CT for Recurrent Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FACBC
ProstaScinct
Sponsored by
David M. Schuster, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

STUDY NOW CLOSED for recruitment

Inclusion Criteria:

  • Patients must be 18 years of age or older.
  • Patients will have been originally diagnosed with localized (Stage T1c, T2, or T3 ) prostate carcinoma and have undergone what was considered definitive therapy for localized disease.
  • In the case of brachytherapy, cryotherapy, or external beam radiation, treatment will have occurred at least 2 years in the past to eliminate patients with so-called "PSA bump."
  • Patient will have suspicion of recurrent prostate carcinoma as defined by: ASTRO criteria of three consecutive rises of PSA or earlier if clinically appropriate, and/or nadir + 2.0 after radiotherapy, and/or greater than 0.3 after prostatectomy.
  • Ability to lie still for PET scanning
  • Patients must be able to provide written informed consent.

Exclusion Criteria:

  • Age less than 18.
  • Greater than T3 disease in past
  • Prior prostatectomy or 2 years since brachytherapy, cryotherapy, or external beam radiation therapy.
  • Does not meet above criteria of suspicious PSA elevation
  • Inability to lie still for PET scanning
  • Cannot provide written informed consent.
  • Bone scan findings characteristic for metastatic prostate carcinoma
  • Less than 2 months since any prior prostate biopsy (to decrease false positive uptake from inflammation).

Sites / Locations

  • Emory University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FACBC PET-CT and ProstaScint CT

Arm Description

Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer will undergo an FACBC PET-CT scan and the ProstaScinct CT.

Outcomes

Primary Outcome Measures

Number of Participants With True Positive Scans Within the Prostate Bed
Total number of participants with positive FACBC PET-CT and ProstaScint CT scans in diagnosis of prostate cancer in the prostate bed validated by prostate biopsy and follow up.
Number of Participants With False Positive Scans Within the Prostate Bed
Total number of participants with positive FACBC PET-CT and ProstaScint scans in the prostate bed that were confirmed as negative by biopsy and or follow up.
Number of Participants With True Negative Scans Within the Prostate Bed
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as negative by biopsy and or follow up.
Number of Participants With False Negative Scans Within the Prostate Bed
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as positive by biopsy and or follow up.
Number of Participants With True Positive Scans Outside the Prostate Bed
Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.
Number of Participants With True Negative Scans Outside the Prostate Bed
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.
Number of Participants With False Positive Scans Outside the Prostate Bed
Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.
Number of Participants With False Negative Scans Outside the Prostate Bed
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.
Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma
Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer outside the prostate bed. [total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)] Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer outside the prostate bed. [ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)] Accuracy = (True positives + true negatives)/all tests Positive predictive value = probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed Negative predictive value = probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed
Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed
Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives) Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives) Accuracy = (True positives + true negatives)/all tests Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed

Secondary Outcome Measures

Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed
Sensitivity = How well ProstaScint imaging is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives) Specificity = How well ProstaScint imaging is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives) Accuracy = (True positives + true negatives)/all tests Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed
Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma
Sensitivity = How well ProstaScint is able to correctly detect when there is prostate cancer outside the prostate bed. [total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)] Specificity = How well ProstaScint is able to correctly detect when there is no prostate cancer outside the prostate bed. [ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)] Accuracy = (True positives + true negatives)/all tests Positive predictive value = the probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed Negative predictive value is the probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed

Full Information

First Posted
November 20, 2007
Last Updated
June 17, 2016
Sponsor
David M. Schuster, MD
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00562315
Brief Title
FACBC PET/CT for Recurrent Prostate Cancer
Official Title
18F-FACBC PET-CT for the Detection and Staging of Recurrent Prostate Carcinoma (CA129356-01).
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David M. Schuster, MD
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Hypothesis:Anti-[18F]FACBC PET-CT will adequately detect local and extraprostatic recurrence, and lead to better characterization of disease status in restaging patients. This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to prostate tissue. The substance is called [18]FACBC and it is given in the form of an injection into a vein. After the substance reaches the prostate, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called [18]FDG is used for PET scans but this substance is eliminated by the kidneys and cannot reach the prostate. This substance called [18]FACBC is not eliminated by the kidneys and may allow tumors in the prostate to be seen better. It is sometimes difficult to tell if a growth on the prostate is cancer with scans or x-rays that are usually done. Anti-[18F]FACBC PET-CT will be compared to ProstaScint (In-capromab pendetide) which is the conventional imaging for prostate cancer. Investigators will be blinded of the intervention. This study will look at how the [18]FACBC goes into the prostate tissue and determine its ability to detect recurrent prostate cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FACBC PET-CT and ProstaScint CT
Arm Type
Other
Arm Description
Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer will undergo an FACBC PET-CT scan and the ProstaScinct CT.
Intervention Type
Drug
Intervention Name(s)
FACBC
Other Intervention Name(s)
Fluciclovine
Intervention Description
Anti-3-[18F]FACBC is an investigational positron emission tomography (PET) radiotracer being studies given intravenously prior to PET scan
Intervention Type
Other
Intervention Name(s)
ProstaScinct
Other Intervention Name(s)
In-Capromab Pendetide
Intervention Description
ProstaScint (In-Capromab Pendetide) is used to image the extent of prostate cancer in standard practice. Capromab is a mouse monoclonal antibody which recognizes prostate specific membrane antigen from prostate cancer cells and normal prostate tissue. It is given intravenously prior to undergoing CT imaging.
Primary Outcome Measure Information:
Title
Number of Participants With True Positive Scans Within the Prostate Bed
Description
Total number of participants with positive FACBC PET-CT and ProstaScint CT scans in diagnosis of prostate cancer in the prostate bed validated by prostate biopsy and follow up.
Time Frame
Up to 5 years
Title
Number of Participants With False Positive Scans Within the Prostate Bed
Description
Total number of participants with positive FACBC PET-CT and ProstaScint scans in the prostate bed that were confirmed as negative by biopsy and or follow up.
Time Frame
Up to 5 years
Title
Number of Participants With True Negative Scans Within the Prostate Bed
Description
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as negative by biopsy and or follow up.
Time Frame
Up to 5 years
Title
Number of Participants With False Negative Scans Within the Prostate Bed
Description
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as positive by biopsy and or follow up.
Time Frame
Up to 5 years
Title
Number of Participants With True Positive Scans Outside the Prostate Bed
Description
Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.
Time Frame
Up to 5 years
Title
Number of Participants With True Negative Scans Outside the Prostate Bed
Description
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.
Time Frame
Up to 5 years
Title
Number of Participants With False Positive Scans Outside the Prostate Bed
Description
Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.
Time Frame
Up to 5 years
Title
Number of Participants With False Negative Scans Outside the Prostate Bed
Description
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.
Time Frame
Up to 5 years
Title
Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma
Description
Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer outside the prostate bed. [total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)] Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer outside the prostate bed. [ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)] Accuracy = (True positives + true negatives)/all tests Positive predictive value = probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed Negative predictive value = probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed
Time Frame
Up to 5 years
Title
Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed
Description
Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives) Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives) Accuracy = (True positives + true negatives)/all tests Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed
Description
Sensitivity = How well ProstaScint imaging is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives) Specificity = How well ProstaScint imaging is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives) Accuracy = (True positives + true negatives)/all tests Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed
Time Frame
Up to 5 years
Title
Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma
Description
Sensitivity = How well ProstaScint is able to correctly detect when there is prostate cancer outside the prostate bed. [total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)] Specificity = How well ProstaScint is able to correctly detect when there is no prostate cancer outside the prostate bed. [ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)] Accuracy = (True positives + true negatives)/all tests Positive predictive value = the probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed Negative predictive value is the probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed
Time Frame
Up to 5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
STUDY NOW CLOSED for recruitment Inclusion Criteria: Patients must be 18 years of age or older. Patients will have been originally diagnosed with localized (Stage T1c, T2, or T3 ) prostate carcinoma and have undergone what was considered definitive therapy for localized disease. In the case of brachytherapy, cryotherapy, or external beam radiation, treatment will have occurred at least 2 years in the past to eliminate patients with so-called "PSA bump." Patient will have suspicion of recurrent prostate carcinoma as defined by: ASTRO criteria of three consecutive rises of PSA or earlier if clinically appropriate, and/or nadir + 2.0 after radiotherapy, and/or greater than 0.3 after prostatectomy. Ability to lie still for PET scanning Patients must be able to provide written informed consent. Exclusion Criteria: Age less than 18. Greater than T3 disease in past Prior prostatectomy or 2 years since brachytherapy, cryotherapy, or external beam radiation therapy. Does not meet above criteria of suspicious PSA elevation Inability to lie still for PET scanning Cannot provide written informed consent. Bone scan findings characteristic for metastatic prostate carcinoma Less than 2 months since any prior prostate biopsy (to decrease false positive uptake from inflammation).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Schuster, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24144687
Citation
Schuster DM, Nieh PT, Jani AB, Amzat R, Bowman FD, Halkar RK, Master VA, Nye JA, Odewole OA, Osunkoya AO, Savir-Baruch B, Alaei-Taleghani P, Goodman MM. Anti-3-[(18)F]FACBC positron emission tomography-computerized tomography and (111)In-capromab pendetide single photon emission computerized tomography-computerized tomography for recurrent prostate carcinoma: results of a prospective clinical trial. J Urol. 2014 May;191(5):1446-53. doi: 10.1016/j.juro.2013.10.065. Epub 2013 Oct 19.
Results Reference
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PubMed Identifier
21493787
Citation
Schuster DM, Savir-Baruch B, Nieh PT, Master VA, Halkar RK, Rossi PJ, Lewis MM, Nye JA, Yu W, Bowman FD, Goodman MM. Detection of recurrent prostate carcinoma with anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid PET/CT and 111In-capromab pendetide SPECT/CT. Radiology. 2011 Jun;259(3):852-61. doi: 10.1148/radiol.11102023. Epub 2011 Apr 14.
Results Reference
background
PubMed Identifier
21825855
Citation
Amzat R, Taleghani P, Savir-Baruch B, Nieh PT, Master VA, Halkar RK, Lewis MM, Faurot M, Bellamy LM, Goodman MM, Schuster DM. Unusual presentations of metastatic prostate carcinoma as detected by anti-3 F-18 FACBC PET/CT. Clin Nucl Med. 2011 Sep;36(9):800-2. doi: 10.1097/RLU.0b013e318219b47e.
Results Reference
background
PubMed Identifier
19387202
Citation
Jani AB, Fox TH, Whitaker D, Schuster DM. Case study of anti-1-amino-3-F-18 fluorocyclobutane-1-carboxylic acid (anti-[F-18] FACBC) to guide prostate cancer radiotherapy target design. Clin Nucl Med. 2009 May;34(5):279-84. doi: 10.1097/RLU.0b013e31819e51e3.
Results Reference
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FACBC PET/CT for Recurrent Prostate Cancer

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